atropine and diphenoxylate

What is the most important information I should know about atropine and diphenoxylate?

If you are giving this medication to a child, pay close attention to the dose. An atropine and diphenoxylate overdose is more likely to occur in a child, and can cause breathing problems or result in death or permanent brain damage.

Use only the liquid form of this medicine in a child younger than 13 years old. Do not give atropine and diphenoxylate tablets to a child under 13.

Drink extra water while you are taking this medication to keep from getting dehydrated.

It may take up to 48 hours of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 10 days of treatment.

What is atropine and diphenoxylate?

Atropine affects the body in many different ways, such as reducing spasms in the bladder, stomach, and intestines.

Diphenoxylate is an antidiarrheal medication.

The combination of atropine and diphenoxylate is used to treat diarrhea.

Atropine and diphenoxylate may also be used for other purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking atropine and diphenoxylate?

Do not use this medication if you are allergic to atropine or diphenoxylate, or if you have:

• jaundice (yellowing of your skin or eyes caused by a liver disorder);
• diarrhea that is caused by bacteria; or
• diarrhea caused by taking an antibiotic.

Before taking atropine and diphenoxylate, tell your doctor if you are allergic to any drugs, or if you have:

• blocked intestines;
• an intestinal disorder such as ulcerative colitis or Crohn's disease;
• liver disease;
• kidney disease;
• heart disease, heart rhythm problems, or high blood pressure;
• glaucoma;
• Down's syndrome;
• a thyroid disorder;
• problems with urination;
• an enlarged prostate;
• asthma or other lung problems; or
• if you are dehydrated;

If you have any of these conditions, you may need a dose adjustment or special tests to safely take atropine and diphenoxylate.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Atropine and diphenoxylate may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not give this medication to a child younger than 2 years old.

How should I take atropine and diphenoxylate?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

If you are giving this medication to a child, pay close attention to the dose. An atropine and diphenoxylate overdose is more likely to occur in a child, and can cause breathing problems or result in death or permanent brain damage.

Use only the liquid form of this medicine in a child younger than 13 years old. Do not give atropine and diphenoxylate tablets to a child under 13.

Take the medicine with a full glass of water. Drink extra water while you are taking atropine and diphenoxylate to keep from getting dehydrated.

It may take up to 48 hours of using the medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 10 days of treatment.

Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Store atropine and diphenoxylate at room temperature away from moisture and heat.

Keep the medication where a child cannot reach it. An overdose of atropine and diphenoxylate can be fatal to a child.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine, or if a child has accidentally swallowed it. An overdose of atropine and diphenoxylate can cause breathing problems and may result in death or permanent brain damage.

Early overdose symptoms may include dry skin, dry mouth or nose, blurred vision, restless feeling, feeling too warm or cold, tingly feeling, and a fast heart rate.

Progressing symptoms of an atropine and diphenoxylate overdose include weakness, pinpoint pupils in the eyes, weak or shallow breathing, fainting, or coma. Report any early overdose symptoms to your doctor as soon as possible.

What should I avoid while taking atropine and diphenoxylate?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol while you are taking this medication. Alcohol can increase some of the side effects of atropine and diphenoxylate.

Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by atropine and diphenoxylate. Tell your doctor if you regularly use any of these other medicines.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink.

What are the possible side effects of atropine and diphenoxylate?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

• stomach pain or bloating;
• ongoing or worsening diarrhea;
• diarrhea that is watery or bloody;
• numbness in your hands or feet;
• depressed mood;
• confusion, unusual thoughts or behavior;
• fast heart rate; or
• urinating less than usual or not at all.

Less serious side effects may include:

• drowsiness, dizziness, headache;
• tired or restless feeling;
• nausea, vomiting, upset stomach, loss of appetite; or
• skin rash, or itching.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect atropine and diphenoxylate?

Before taking atropine and diphenoxylate, tell your doctor if you are using any of the following drugs:

• a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or
• an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate).

This list is not complete and there may be other drugs that can interact with atropine and diphenoxylate. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about atropine and diphenoxylate.